Recall Z-0845-2018 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Toshiba American Medical Systems Inc
INFX-8000H Fluoroscopic X-Ray Systems
| Date | Dec 29, 2017 |
| Status | Terminated |
| Reason | During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error. |
| Root cause | Process control |
| Action | A recall notification letter was sent to affected consignees on 12/29/2017. The following information was included in the notification letter: Should this problem occur prior to the above corrective action and in the middle of a clinical case, you will be able continue the case tentatively. The x-ray emissions will be still available and the inhibited ceiling support device can be overridden by pressing the override switch on the left side of the operation console. If any abnormalities are found during use, please stop using your system and contact your Toshiba service representative. Please s |
| Quantity | 2 units |
| Distribution | United States |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082830 | INFX-8000H, INFINIX-I Toshiba America Medical Systems, In.C, Oct 10, 2008 |